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Evaluating Hearing Aid Service Delivery Models

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ClinicalTrials.gov Identifier: NCT01788423
Recruitment Status : Recruiting
First Posted : February 11, 2013
Last Update Posted : June 9, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to compare the outcomes for two different hearing-aid delivery models. In one model, the audiologist selects and fits the hearing aid and, in the other model, the consumer does this directly.

Condition or disease Intervention/treatment
Presbycusis Aging Hearing Loss Device: hearing aid

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating Hearing Aid Service Delivery Models
Study Start Date : November 2012
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hearing Aids
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Audiologist-Based
Audiologist selects hearing aid for patient
Device: hearing aid
All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.
Experimental: Consumer Decides
Consumer selects hearing aid
Device: hearing aid
All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.
Placebo Comparator: Placebo
Patient fitted with hearing aid that is acoustically transparent.
Device: hearing aid
All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.
Experimental: Customer decides with limited inclusion/exclusion criteria
Consumer selects hearing aid with limited inclusion/exclusion criteria to closely simulate an actual over the counter dispensary.
Device: hearing aid
All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline on the Profile of Hearing Aid Performance [ Time Frame: two times: at hearing-aid fit and at 6-weeks post-fit ]

Secondary Outcome Measures :
  1. Change from baseline on the Connected Speech Test [ Time Frame: two times: at hearing-aid fit and at 6-weeks post-fit ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: (for groups 1-4)

  • 55-79 yrs of age
  • Native English speaker
  • no prior hearing aid use
  • ability to read 18 point font

Exclusion Criteria: (for groups 1-3)

  • hearing loss too severe or too mild for hearing aid
  • middle-ear conductive pathology present
  • asymmetrical hearing loss
  • presence of dementia, Parkinson's disease, or other neurological disorder

Exclusion Criteria : (for groups 1-4)

- subject not interested in purchasing hearing aids

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01788423


Contacts
Contact: Christine M Herring, BA 866-261-0020 chmherri@indiana.edu

Locations
United States, Indiana
IU Department of Speech & Hearing Sciences Recruiting
Bloomington, Indiana, United States, 47405-7002
Contact: Christine M Herring, BA    812-856-2519    chmherri@indiana.edu   
Contact: Larry E. Humes, PhD    812-855-3507    humes@indiana.edu   
Principal Investigator: Larry E. Humes, PhD         
Sponsors and Collaborators
Indiana University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Principal Investigator: Larry E. Humes, PhD Indiana University
More Information

Responsible Party: Larry Humes, Distinguished Professor, Indiana University
ClinicalTrials.gov Identifier: NCT01788423     History of Changes
Other Study ID Numbers: 1111007504
First Posted: February 11, 2013    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Larry Humes, Indiana University:
presbycusis
hearing aids

Additional relevant MeSH terms:
Hearing Loss
Presbycusis
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hearing Loss, Sensorineural